Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of 13 Weeks of the Selective Androgen Receptor Modulator (SARM) GSK2881078 in Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT03359473)
NCT ID: NCT03359473
Last Updated: 2020-07-15
Results Overview
SBP and DBP were measured in a seated position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Safety Population comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
COMPLETED
PHASE2
97 participants
Baseline (Day 1, Pre-dose), Days 14, 28, 56 and 90
2020-07-15
Participant Flow
This was a Phase II, double-blind, randomized, multicenter study to evaluate the safety and efficacy of GSK2881078 over 13 weeks of once daily oral dosing, first time administered in older men and post-menopausal female participants with chronic obstructive pulmonary disease (COPD) and muscle weakness, participating in home exercise.
A total of 200 participants were screened and 97 participants were enrolled in this study. Of which, 96 participants were randomized and received the study treatment. The remaining 1 participant was randomized without fulfilling the inclusion and exclusion criteria and therefore did not receive study medication.
Participant milestones
| Measure |
Placebo- Female Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
Placebo- Male Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
24
|
25
|
|
Overall Study
COMPLETED
|
21
|
18
|
18
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
6
|
5
|
Reasons for withdrawal
| Measure |
Placebo- Female Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
Placebo- Male Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
1
|
0
|
|
Overall Study
Protocol-defined stopping criteria
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of 13 Weeks of the Selective Androgen Receptor Modulator (SARM) GSK2881078 in Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Placebo- Female Participants
n=23 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=24 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
Placebo- Male Participants
n=24 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=25 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64.7 Years
STANDARD_DEVIATION 7.16 • n=5 Participants
|
64.2 Years
STANDARD_DEVIATION 7.93 • n=7 Participants
|
64.0 Years
STANDARD_DEVIATION 7.27 • n=5 Participants
|
67.2 Years
STANDARD_DEVIATION 6.08 • n=4 Participants
|
65.1 Years
STANDARD_DEVIATION 7.14 • n=21 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White-White/Caucasian/European Heritage
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 14, 28, 56 and 90Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
SBP and DBP were measured in a seated position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Safety Population comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
Outcome measures
| Measure |
Placebo- Male Participants
n=23 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=24 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=22 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=23 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP,Day 90,n=21,18,18,20
|
-0.1 Millimeters of mercury
Standard Deviation 12.98
|
0.6 Millimeters of mercury
Standard Deviation 6.95
|
-1.0 Millimeters of mercury
Standard Deviation 6.47
|
2.9 Millimeters of mercury
Standard Deviation 8.37
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP,Day 14,n=22,23,23,24
|
-2.1 Millimeters of mercury
Standard Deviation 9.33
|
3.1 Millimeters of mercury
Standard Deviation 11.65
|
3.0 Millimeters of mercury
Standard Deviation 19.63
|
2.1 Millimeters of mercury
Standard Deviation 11.03
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP,Day 28,n=22,20,23,24
|
2.6 Millimeters of mercury
Standard Deviation 14.39
|
5.8 Millimeters of mercury
Standard Deviation 9.49
|
3.7 Millimeters of mercury
Standard Deviation 12.76
|
-0.1 Millimeters of mercury
Standard Deviation 12.82
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP,Day 56,n=21,19,20,21
|
-2.4 Millimeters of mercury
Standard Deviation 17.68
|
1.3 Millimeters of mercury
Standard Deviation 9.12
|
3.3 Millimeters of mercury
Standard Deviation 14.96
|
7.8 Millimeters of mercury
Standard Deviation 16.38
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP,Day 90,n=21,18,18,20
|
-4.2 Millimeters of mercury
Standard Deviation 18.52
|
5.8 Millimeters of mercury
Standard Deviation 18.61
|
1.0 Millimeters of mercury
Standard Deviation 14.23
|
7.6 Millimeters of mercury
Standard Deviation 15.56
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP,Day 14,n=22,23,23,24
|
-3.4 Millimeters of mercury
Standard Deviation 6.20
|
-0.4 Millimeters of mercury
Standard Deviation 7.47
|
1.9 Millimeters of mercury
Standard Deviation 6.88
|
1.1 Millimeters of mercury
Standard Deviation 6.93
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP,Day 28,n=22,20,23,24
|
0.7 Millimeters of mercury
Standard Deviation 7.90
|
1.0 Millimeters of mercury
Standard Deviation 5.36
|
3.6 Millimeters of mercury
Standard Deviation 7.08
|
1.4 Millimeters of mercury
Standard Deviation 7.58
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP,Day 56,n=21,19,20,21
|
-2.5 Millimeters of mercury
Standard Deviation 10.38
|
-1.6 Millimeters of mercury
Standard Deviation 8.16
|
2.1 Millimeters of mercury
Standard Deviation 7.00
|
2.9 Millimeters of mercury
Standard Deviation 6.07
|
PRIMARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 14, 28, 56 and 90Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Heart rate was measured in a seated position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Outcome measures
| Measure |
Placebo- Male Participants
n=23 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=24 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=22 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=23 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Heart Rate
Day 14,n=22,23,23,24
|
1.7 Beats per minute
Standard Deviation 10.61
|
-0.4 Beats per minute
Standard Deviation 6.60
|
-0.7 Beats per minute
Standard Deviation 9.79
|
3.3 Beats per minute
Standard Deviation 9.16
|
|
Change From Baseline in Heart Rate
Day 28,n=22,20,23,24
|
4.6 Beats per minute
Standard Deviation 10.71
|
-1.7 Beats per minute
Standard Deviation 10.71
|
2.2 Beats per minute
Standard Deviation 8.11
|
2.1 Beats per minute
Standard Deviation 9.64
|
|
Change From Baseline in Heart Rate
Day 56,n=21,19,20,21
|
2.8 Beats per minute
Standard Deviation 7.17
|
0.2 Beats per minute
Standard Deviation 6.36
|
0.2 Beats per minute
Standard Deviation 8.87
|
-1.0 Beats per minute
Standard Deviation 8.81
|
|
Change From Baseline in Heart Rate
Day 90,n=21,18,18,20
|
7.4 Beats per minute
Standard Deviation 10.23
|
-0.6 Beats per minute
Standard Deviation 8.17
|
1.1 Beats per minute
Standard Deviation 7.99
|
2.3 Beats per minute
Standard Deviation 10.34
|
PRIMARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 14, 28, 56 and 90Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Twelve-lead electrocardiograms (ECG) were obtained using an automated ECG machine to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Outcome measures
| Measure |
Placebo- Male Participants
n=23 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=24 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=22 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=23 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF) and QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB)
QTcF Interval,Day 90,n=20,17,18,17
|
2.657 Milliseconds
Standard Deviation 12.2002
|
-11.804 Milliseconds
Standard Deviation 11.7207
|
3.600 Milliseconds
Standard Deviation 10.3526
|
-12.627 Milliseconds
Standard Deviation 11.5776
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF) and QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB)
QTcB Interval,Day 90,n=3,3,2,6
|
32.000 Milliseconds
Standard Deviation 1.4142
|
-10.278 Milliseconds
Standard Deviation 9.6088
|
1.333 Milliseconds
Standard Deviation 15.9199
|
-13.111 Milliseconds
Standard Deviation 3.0972
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF) and QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB)
PR interval,Day 14,n=22,23,22,24
|
-2.455 Milliseconds
Standard Deviation 12.6556
|
-2.875 Milliseconds
Standard Deviation 24.3370
|
-1.303 Milliseconds
Standard Deviation 9.9261
|
-0.377 Milliseconds
Standard Deviation 7.2588
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF) and QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB)
PR interval,,Day 28,n=22,20,22,24
|
-2.333 Milliseconds
Standard Deviation 17.5966
|
4.139 Milliseconds
Standard Deviation 15.5796
|
-0.061 Milliseconds
Standard Deviation 7.9340
|
-4.717 Milliseconds
Standard Deviation 19.3177
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF) and QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB)
PR interval,,Day 56,n=21,19,20,21
|
0.483 Milliseconds
Standard Deviation 7.5436
|
10.444 Milliseconds
Standard Deviation 27.5133
|
1.302 Milliseconds
Standard Deviation 12.1220
|
0.596 Milliseconds
Standard Deviation 6.5250
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF) and QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB)
PR interval,,Day 90,n=21,18,17,20
|
-3.373 Milliseconds
Standard Deviation 9.6845
|
3.033 Milliseconds
Standard Deviation 20.7947
|
-0.270 Milliseconds
Standard Deviation 9.3111
|
-6.167 Milliseconds
Standard Deviation 28.9117
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF) and QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB)
QRS Duration,Day 14,n=22,23,23,24
|
-0.464 Milliseconds
Standard Deviation 7.4791
|
1.167 Milliseconds
Standard Deviation 4.1772
|
4.364 Milliseconds
Standard Deviation 22.8107
|
1.362 Milliseconds
Standard Deviation 10.4736
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF) and QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB)
QRS Duration,Day 28,n=22,20,23,24
|
-1.478 Milliseconds
Standard Deviation 5.5047
|
-0.542 Milliseconds
Standard Deviation 3.3547
|
1.000 Milliseconds
Standard Deviation 7.7014
|
6.200 Milliseconds
Standard Deviation 28.2707
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF) and QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB)
QRS Duration,Day 56,n=21,19,20,21
|
-1.100 Milliseconds
Standard Deviation 4.9631
|
-0.413 Milliseconds
Standard Deviation 4.6271
|
-0.095 Milliseconds
Standard Deviation 5.9639
|
1.842 Milliseconds
Standard Deviation 5.4096
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF) and QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB)
QRS Duration,Day 90,n=21,18,18,20
|
1.333 Milliseconds
Standard Deviation 25.4163
|
1.333 Milliseconds
Standard Deviation 6.3005
|
-2.397 Milliseconds
Standard Deviation 14.1494
|
-2.444 Milliseconds
Standard Deviation 4.5360
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF) and QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB)
QT Interval,Day 14,n=22,23,23,24
|
-0.638 Milliseconds
Standard Deviation 22.5431
|
-0.597 Milliseconds
Standard Deviation 15.5697
|
0.576 Milliseconds
Standard Deviation 19.8239
|
-14.290 Milliseconds
Standard Deviation 17.7216
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF) and QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB)
QT Interval,Day 28,n=22,20,23,24
|
-4.203 Milliseconds
Standard Deviation 23.3733
|
-1.750 Milliseconds
Standard Deviation 22.6539
|
-1.333 Milliseconds
Standard Deviation 23.5300
|
-16.133 Milliseconds
Standard Deviation 26.2775
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF) and QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB)
QT Interval,Day 56,n=21,19,20,21
|
-1.533 Milliseconds
Standard Deviation 20.5897
|
-1.857 Milliseconds
Standard Deviation 14.6881
|
-0.127 Milliseconds
Standard Deviation 13.5567
|
-13.947 Milliseconds
Standard Deviation 18.3657
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF) and QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB)
QT Interval,Day 90,n=21,18,18,20
|
-4.574 Milliseconds
Standard Deviation 17.1825
|
-5.167 Milliseconds
Standard Deviation 17.7759
|
4.063 Milliseconds
Standard Deviation 16.9160
|
-16.352 Milliseconds
Standard Deviation 20.7511
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF) and QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB)
QTcF Interval,Day 14,n=21,21,21,21
|
-1.235 Milliseconds
Standard Deviation 11.3507
|
-2.698 Milliseconds
Standard Deviation 9.7085
|
1.749 Milliseconds
Standard Deviation 11.7762
|
-7.143 Milliseconds
Standard Deviation 9.2710
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF) and QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB)
QTcF Interval,Day 28,n=21,19,21,21
|
-0.489 Milliseconds
Standard Deviation 10.5492
|
-4.340 Milliseconds
Standard Deviation 12.8445
|
0.362 Milliseconds
Standard Deviation 15.7742
|
-12.930 Milliseconds
Standard Deviation 11.7707
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF) and QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB)
QTcF Interval,Day 56,n=20,18,18,18
|
1.093 Milliseconds
Standard Deviation 10.0462
|
-3.357 Milliseconds
Standard Deviation 10.5127
|
1.333 Milliseconds
Standard Deviation 8.5039
|
-12.222 Milliseconds
Standard Deviation 10.2975
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF) and QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB)
QTcB Interval,Day 14,n=4,5,4,7
|
12.917 Milliseconds
Standard Deviation 13.6582
|
0.571 Milliseconds
Standard Deviation 11.0180
|
-4.333 Milliseconds
Standard Deviation 26.2100
|
2.193 Milliseconds
Standard Deviation 12.5624
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF) and QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB)
QTcB Interval,Day 28,n=4,3,4,7
|
-7.667 Milliseconds
Standard Deviation 8.8192
|
-10.238 Milliseconds
Standard Deviation 11.6678
|
-1.167 Milliseconds
Standard Deviation 12.1549
|
13.667 Milliseconds
Standard Deviation 24.7678
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF) and QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB)
QTcB Interval,Day 56,n=3,3,4,6
|
13.417 Milliseconds
Standard Deviation 8.0017
|
-9.500 Milliseconds
Standard Deviation 7.2411
|
-13.556 Milliseconds
Standard Deviation 11.3741
|
-7.667 Milliseconds
Standard Deviation 9.7125
|
PRIMARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and up to Day 132Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the analysis of following hematology parameters: hemoglobin (Hb), lymphocyte count (Lympho), neutrophil count (Neutro) and platelet count (PC). The laboratory parameters were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Only those participants with increase to grade 3 and increase to grade 4 are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=24 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=25 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=23 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=22 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Lympho, Lymph count decreased, increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Neutro,Neutro count decreased,increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Hb, Hb increased, increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Hb, Hb increased, increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Hb, Anemia, increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Hb, Anemia, increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Lympho, Lymph count decreased, increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Lympho, Lymph count increased, increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Lympho, Lymph count increased, increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Neutro,Neutro count decreased,increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
PC, PC decreased,increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
PC, PC decreased,increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
PC, PC increased,increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
PC, PC increased,increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and up to Day 132Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), bilirubin (Bil),calcium (Ca), cholesterol (Chol), creatinine (Creat), glucose(Gl), phosphate (Phos), potassium (Pot) and sodium (Sod). The laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Values (Hyper and hypo) for Ca, Gl, Pot, Phos and Sod is presented. Only those participants with increase to grade 3 and increase to grade 4 are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=24 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=25 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=23 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=22 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
AST, AST increased, increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
AST, AST increased, increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Bil, Blood Bil increased, increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Ca, Hyper,increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Creat, Creat increased,increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Phos, Hyper,increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Phos, Hyper,increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Pot, Hyper,increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Pot, Hyper,increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Pot, Hypo,increase to Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Pot, Hypo,increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
ALT, ALT increased, increase to Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
ALT, ALT increased, increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
ALP, ALP increased, increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
ALP, ALP increased, increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Bil, Blood Bil increased, increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Ca, Hyper,increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Ca, Hypo,increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Ca, Hypo,increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Chol, Chol high,increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Chol, Chol high,increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Creat, Creat increased,increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Gl, Hyper,increase to Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Gl, Hyper,increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Gl, Hypo,increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Gl, Hypo,increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Phos, Hypo,increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Phos, Hypo,increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Sod, Hyper,increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Sod, Hyper,increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Sod, Hypo,increase to Grade 3
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Sod, Hypo,increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 28, 56 and 90Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Outcome measures
| Measure |
Placebo- Male Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Urinalysis Parameter; Specific Gravity: Placebo-Female Participants
Day 28,n=1
|
—
|
—
|
0.0030 Ratio
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
—
|
|
Change From Baseline in Urinalysis Parameter; Specific Gravity: Placebo-Female Participants
Day 56,n=1
|
—
|
—
|
0.0020 Ratio
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
—
|
|
Change From Baseline in Urinalysis Parameter; Specific Gravity: Placebo-Female Participants
Day 90,n=21
|
—
|
—
|
-0.0006 Ratio
Standard Deviation 0.00612
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 14 and 90Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Outcome measures
| Measure |
Placebo- Male Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=18 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Urinalysis Parameter; Specific Gravity: GSK2881078 1.0 mg- Female Participants
Day 14,n=1
|
—
|
—
|
0.000 Ratio
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
—
|
|
Change From Baseline in Urinalysis Parameter; Specific Gravity: GSK2881078 1.0 mg- Female Participants
Day 90,n=18
|
—
|
—
|
0.0049 Ratio
Standard Deviation 0.00711
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 28 and 90Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Outcome measures
| Measure |
Placebo- Male Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=19 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=20 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Urinalysis Parameter; Specific Gravity: Male Participants
Day 28,n=1,1
|
—
|
—
|
-0.0080 Ratio
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
0.0040 Ratio
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Urinalysis Parameter; Specific Gravity: Male Participants
Day 90,n=19,20
|
—
|
—
|
0.0017 Ratio
Standard Deviation 0.00870
|
0.0018 Ratio
Standard Deviation 0.00610
|
PRIMARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 28, 56 and 90Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Outcome measures
| Measure |
Placebo- Male Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Urinalysis Parameter; Potential of Hydrogen (pH): Placebo- Female Participants
Day 28,n=1
|
—
|
—
|
0.0000 pH
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
—
|
|
Change From Baseline in Urinalysis Parameter; Potential of Hydrogen (pH): Placebo- Female Participants
Day 56,n=1
|
—
|
—
|
-0.5000 pH
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
—
|
|
Change From Baseline in Urinalysis Parameter; Potential of Hydrogen (pH): Placebo- Female Participants
Day 90,n=21
|
—
|
—
|
0.0000 pH
Standard Deviation 0.80623
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 14 and 90Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Outcome measures
| Measure |
Placebo- Male Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=18 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Urinalysis Parameter; pH: GSK2881078 1.0 mg- Female Participants
Day 14,n=1
|
—
|
—
|
1.0000 pH
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
—
|
|
Change From Baseline in Urinalysis Parameter; pH: GSK2881078 1.0 mg- Female Participants
Day 90,n=18
|
—
|
—
|
-0.1111 pH
Standard Deviation 0.60768
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 28 and 90Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Outcome measures
| Measure |
Placebo- Male Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=19 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=20 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Urinalysis Parameter; pH: Male Participants
Day 28,n=1,1
|
—
|
—
|
1.0000 pH
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
0.5000 pH
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
|
Change From Baseline in Urinalysis Parameter; pH: Male Participants
Day 90,n=19,20
|
—
|
—
|
-0.1579 pH
Standard Deviation 0.72749
|
0.3000 pH
Standard Deviation 0.71451
|
PRIMARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and up to Day 132Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
Urine samples were collected to analyze parameters including glucose, occult blood (OB) and protein levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as increase to trace, increase to 1+ (low concentrations present), increase to 2+ (moderate concentrations present) and increase to 3+ (high concentrations present) indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for worst-case post-Baseline relative to Baseline is presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=23 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=24 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=23 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Urinalysis Dipstick Results Post-Baseline Relative to Baseline
Glucose: increase to 3+
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results Post-Baseline Relative to Baseline
OB: increase to trace
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results Post-Baseline Relative to Baseline
OB: increase to 1+
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results Post-Baseline Relative to Baseline
OB: increase to 3+
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results Post-Baseline Relative to Baseline
Protein: increase to trace
|
3 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Dipstick Results Post-Baseline Relative to Baseline
Glucose: increase to 2+
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results Post-Baseline Relative to Baseline
OB: increase to 2+
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Dipstick Results Post-Baseline Relative to Baseline
Protein: increase to 1+
|
1 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Urinalysis Dipstick Results Post-Baseline Relative to Baseline
Protein: increase to 2+
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results Post-Baseline Relative to Baseline
Protein: increase to 3+
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results Post-Baseline Relative to Baseline
Glucose: increase to trace
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results Post-Baseline Relative to Baseline
Glucose: increase to 1+
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 132Population: Safety Population
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Number of participants who had SAEs and non-SAEs are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=24 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=25 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=23 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=24 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events
SAEs
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events
Non-SAEs
|
13 Participants
|
17 Participants
|
15 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 28Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
Lower extremity strength was measured as 1-RM on a leg press device. Participants continued with a one set of 5 to 10 repetitions of lifting weights using 40 to 60% of estimated maximum, after warm up. Participants, then lifted progressively heavier weights in steps, with each step separated by an appropriate rest period, until participant could not complete the lift. The last successfully completed lift was recorded as the 1-RM. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Percentage change from Baseline was calculated by 100\*\[(post-dose value minus Baseline value)/ Baseline value\]. Adjusted means and standard error (SE) are presented. Analysis Population comprised of the participants in the 'All Participants (all randomized participants who received at least one dose of study medication)' Population having Baseline and at least one post-Baseline assessment of the treatment the participant was randomized to.
Outcome measures
| Measure |
Placebo- Male Participants
n=22 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=23 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=20 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Percentage Change From Baseline in Maximum Leg Press Strength Following 1 Repetition Maximum (1-RM) at Day 28
|
1.55 Percentage change
Standard Error 2.940
|
9.35 Percentage change
Standard Error 2.848
|
4.82 Percentage change
Standard Error 2.406
|
9.34 Percentage change
Standard Error 2.459
|
PRIMARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 56Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
Lower extremity strength was measured as 1-RM on a leg press device. Participants continued with a one set of 5 to 10 repetitions of lifting weights using 40 to 60% of estimated maximum, after warm up. Participants, then lifted progressively heavier weights in steps, with each step separated by an appropriate rest period, until participant could not complete the lift. The last successfully completed lift was recorded as the 1-RM. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Percentage change from Baseline was calculated by 100\*\[(post-dose value minus Baseline value)/ Baseline value\]. Adjusted means and SE are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=21 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=21 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=20 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=18 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Percentage Change From Baseline in Maximum Leg Press Strength Following 1 Repetition Maximum (1-RM) at Day 56
|
5.73 Percentage change
Standard Error 3.921
|
11.07 Percentage change
Standard Error 3.922
|
0.08 Percentage change
Standard Error 2.787
|
16.78 Percentage change
Standard Error 2.925
|
PRIMARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 90Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
Lower extremity strength was measured as 1-RM on a leg press device. Participants continued with a one set of 5 to 10 repetitions of lifting weights using 40 to 60% of estimated maximum, after warm up. Participants, then lifted progressively heavier weights in steps, with each step separated by an appropriate rest period, until participant could not complete the lift. The last successfully completed lift was recorded as the 1-RM. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Percentage change from Baseline was calculated by 100\*\[(post-dose value minus Baseline value)/ Baseline value\]. Adjusted means and SE are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=18 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=20 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=19 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=18 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Percentage Change From Baseline in Maximum Leg Press Strength Following 1 Repetition Maximum (1-RM) at Day 90
|
7.15 Percentage change
Standard Error 2.759
|
14.17 Percentage change
Standard Error 2.632
|
12.76 Percentage change
Standard Error 4.061
|
17.93 Percentage change
Standard Error 4.179
|
PRIMARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 28Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
Lower extremity strength was measured as 1-RM on a leg press device. Participants continued with a one set of 5 to 10 repetitions of lifting weights using 40 to 60% of estimated maximum, after warm up. Participants, then lifted progressively heavier weights in steps, with each step separated by an appropriate rest period, until participant could not complete the lift. The last successfully completed lift was recorded as the 1-RM. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=22 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=23 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=20 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Maximum Leg Press Strength Following 1 Repetition Maximum (1-RM) at Day 28
|
3.0 Kilograms
Standard Error 5.06
|
16.5 Kilograms
Standard Error 4.90
|
4.2 Kilograms
Standard Error 3.01
|
10.0 Kilograms
Standard Error 3.08
|
PRIMARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 56Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
Lower extremity strength was measured as 1-RM on a leg press device. Participants continued with a one set of 5 to 10 repetitions of lifting weights using 40 to 60% of estimated maximum, after warm up. Participants, then lifted progressively heavier weights in steps, with each step separated by an appropriate rest period, until participant could not complete the lift. The last successfully completed lift was recorded as the 1-RM. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=21 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=21 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=20 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=18 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Maximum Leg Press Strength Following 1 Repetition Maximum (1-RM) at Day 56
|
8.3 Kilograms
Standard Error 7.69
|
15.7 Kilograms
Standard Error 7.69
|
0.6 Kilograms
Standard Error 4.29
|
21.3 Kilograms
Standard Error 4.50
|
PRIMARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 90Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
Lower extremity strength was measured as 1-RM on a leg press device. Participants continued with a one set of 5 to 10 repetitions of lifting weights using 40 to 60% of estimated maximum, after warm up. Participants, then lifted progressively heavier weights in steps, with each step separated by an appropriate rest period, until participant could not complete the lift. The last successfully completed lift was recorded as the 1-RM. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=18 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=20 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=19 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=18 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Maximum Leg Press Strength Following 1 Repetition Maximum (1-RM) at Day 90
|
14.2 Kilograms
Standard Error 5.17
|
26.0 Kilograms
Standard Error 4.91
|
12.3 Kilograms
Standard Error 4.31
|
20.3 Kilograms
Standard Error 4.45
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 28Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
Participants were asked to lie on a padded platform while a mechanical arm passed over their body. Appendicular lean mass was calculated from the regional lean mass measurements of the arms and legs using DXA. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=20 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=22 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=19 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Appendicular Lean Mass as Assessed by Dual-energy X-ray Absorptiometry (DXA) at Day 28
|
0.055 Kilograms
Standard Error 0.1920
|
0.346 Kilograms
Standard Error 0.1831
|
-0.240 Kilograms
Standard Error 0.0974
|
0.642 Kilograms
Standard Error 0.1023
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 56Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
Participants were asked to lie on a padded platform while a mechanical arm passed over their body. Appendicular lean mass was calculated from the regional lean mass measurements of the arms and legs using DXA. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=17 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=18 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=17 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Appendicular Lean Mass as Assessed by Dual-energy X-ray Absorptiometry (DXA) at Day 56
|
-0.464 Kilograms
Standard Error 0.1887
|
0.663 Kilograms
Standard Error 0.1829
|
-0.134 Kilograms
Standard Error 0.1410
|
0.848 Kilograms
Standard Error 0.1540
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 90Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
Participants were asked to lie on a padded platform while a mechanical arm passed over their body. Appendicular lean mass was calculated from the regional lean mass measurements of the arms and legs using DXA. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=15 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=18 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=17 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Appendicular Lean Mass as Assessed by Dual-energy X-ray Absorptiometry (DXA) at Day 90
|
-0.225 Kilograms
Standard Error 0.2306
|
0.899 Kilograms
Standard Error 0.2117
|
-0.434 Kilograms
Standard Error 0.1657
|
0.946 Kilograms
Standard Error 0.1818
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 28Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
Participants were asked to lie on a padded platform while a mechanical arm passed over their body. Total lean mass was measured using DXA. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=20 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=22 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=19 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Total Lean Mass as Assessed by Dual-energy X-ray Absorptiometry (DXA) at Day 28
|
0.075 Kilograms
Standard Error 0.3004
|
0.998 Kilograms
Standard Error 0.2869
|
-0.017 Kilograms
Standard Error 0.2004
|
1.150 Kilograms
Standard Error 0.2106
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 56Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
Participants were asked to lie on a padded platform while a mechanical arm passed over their body. Total lean mass was measured using DXA. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=17 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=18 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=17 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Total Lean Mass as Assessed by Dual-energy X-ray Absorptiometry (DXA) at Day 56
|
-0.373 Kilograms
Standard Error 0.3820
|
1.327 Kilograms
Standard Error 0.3700
|
-0.564 Kilograms
Standard Error 0.2372
|
1.522 Kilograms
Standard Error 0.2587
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 90Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
Participants were asked to lie on a padded platform while a mechanical arm passed over their body. Total lean mass was measured using DXA. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=15 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=18 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=17 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Total Lean Mass as Assessed by Dual-energy X-ray Absorptiometry (DXA) at Day 90
|
-0.424 Kilograms
Standard Error 0.5056
|
1.689 Kilograms
Standard Error 0.4666
|
-0.531 Kilograms
Standard Error 0.3349
|
1.577 Kilograms
Standard Error 0.3666
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 28Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
Participants were assessed for balance, time for chair rise and gait speed. These are the three components of SPPB. Each component was scored from 0 to 4. The total SPPB score was calculated by taking sum of scores of all 3 components, which ranged from 0 (worst performance) to 12 (best performance). Higher scores indicated better performance. Scores 10 to 12 indicated 'fit/normal' and scores \<=7 indicated frail participant. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=22 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=23 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=20 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Total Short Physical Performance Battery (SPPB) Score at Day 28
|
0.2 Scores on a scale
Standard Error 0.19
|
0.3 Scores on a scale
Standard Error 0.18
|
0.3 Scores on a scale
Standard Error 0.25
|
0.4 Scores on a scale
Standard Error 0.26
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 56Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
Participants were assessed for balance, time for chair rise and gait speed. These are the three components of SPPB. Each component was scored from 0 to 4. The total SPPB score was calculated by taking sum of scores of all 3 components, which ranged from 0 (worst performance) to 12 (best performance). Higher scores indicated better performance. Scores 10 to 12 indicated 'fit/normal' and scores \<=7 indicated frail participant. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=21 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=21 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=19 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Total Short Physical Performance Battery (SPPB) Score at Day 56
|
0.1 Scores on a scale
Standard Error 0.24
|
0.4 Scores on a scale
Standard Error 0.24
|
0.4 Scores on a scale
Standard Error 0.24
|
0.4 Scores on a scale
Standard Error 0.25
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 90Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
Participants were assessed for balance, time for chair rise and gait speed. These are the three components of SPPB. Each component was scored from 0 to 4. The total SPPB score was calculated by taking sum of scores of all 3 components, which ranged from 0 (worst performance) to 12 (best performance). Higher scores indicated better performance. Scores 10 to 12 indicated 'fit/normal' and scores \<=7 indicated frail participant. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=18 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=20 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=18 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Total Short Physical Performance Battery (SPPB) Score at Day 90
|
0.4 Scores on a scale
Standard Error 0.23
|
0.5 Scores on a scale
Standard Error 0.22
|
0.3 Scores on a scale
Standard Error 0.26
|
0.5 Scores on a scale
Standard Error 0.28
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 28Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
'Time for chair rise' is one of the 3 components of SPPB, which was assessed by repeated chair stand test and calculated as time for five successful chair stands measured in seconds. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=22 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=23 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=20 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in 'Time for Chair Rise' as Assessed by SPPB at Day 28
|
-0.464 Seconds
Standard Error 0.3841
|
-0.537 Seconds
Standard Error 0.3763
|
-0.644 Seconds
Standard Error 0.6333
|
-1.196 Seconds
Standard Error 0.6491
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 56Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
'Time for chair rise' is one of the 3 components of SPPB, which was assessed by repeated chair stand test and calculated as time for five successful chair stands measured in seconds. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=21 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=21 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=19 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in 'Time for Chair Rise' as Assessed by SPPB at Day 56
|
-0.323 Seconds
Standard Error 0.5294
|
-0.160 Seconds
Standard Error 0.5282
|
-1.207 Seconds
Standard Error 0.5912
|
-2.023 Seconds
Standard Error 0.6124
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 90Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
'Time for chair rise' is one of the 3 components of SPPB, which was assessed by repeated chair stand test and calculated as time for five successful chair stands measured in seconds. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=18 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=20 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=18 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in 'Time for Chair Rise' as Assessed by SPPB at Day 90
|
1.144 Seconds
Standard Error 1.4013
|
-0.793 Seconds
Standard Error 1.3401
|
-1.070 Seconds
Standard Error 0.6956
|
-2.030 Seconds
Standard Error 0.7362
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 28Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
''Time for fastest walk for 4 meter' was assessed by SPPB using 4 meter gait speed test. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=22 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=23 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=20 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in 'Time for Fastest Walk for 4 Meter' as Assessed by SPPB at Day 28
|
-0.167 Seconds
Standard Error 0.1133
|
-0.110 Seconds
Standard Error 0.1108
|
-0.236 Seconds
Standard Error 0.1132
|
-0.277 Seconds
Standard Error 0.1161
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 56Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
'Time for fastest walk for 4 meter' was assessed by SPPB using 4 meter gait speed test. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=21 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=21 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=19 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in 'Time for Fastest Walk for 4 Meter' as Assessed by SPPB at Day 56
|
-0.093 Seconds
Standard Error 0.1437
|
-0.284 Seconds
Standard Error 0.1438
|
0.010 Seconds
Standard Error 0.1487
|
-0.276 Seconds
Standard Error 0.1560
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 90Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
'Time for fastest walk for 4 meter' was assessed by SPPB using 4 meter gait speed test. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=18 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=20 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=18 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in 'Time for Fastest Walk for 4 Meter' as Assessed by SPPB at Day 90
|
-0.130 Seconds
Standard Error 0.1331
|
-0.360 Seconds
Standard Error 0.1275
|
-0.043 Seconds
Standard Error 0.2194
|
-0.055 Seconds
Standard Error 0.2361
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 90Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
The endurance shuttle walk test is a CWR test requiring the participant to walk around a flat 10 meter track at a constant individualized pace. The test was externally paced, set to elicit a maximal exercise response (pace was based on a fixed percentage of prior incremental shuttle walk test performance, which determined a participant's peak exercise capacity). CWR duration is the time in seconds required by a participant to cover a flat 10 meter track during this test. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using analysis of covariance (ANCOVA) model. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Outcome measures
| Measure |
Placebo- Male Participants
n=18 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=20 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=19 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=16 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Constant Work Rate (CWR) Duration From Endurance Shuttle Walking Test
|
105.1 Seconds
Standard Error 54.94
|
-44.2 Seconds
Standard Error 51.97
|
-6.5 Seconds
Standard Error 26.78
|
4.6 Seconds
Standard Error 29.25
|
SECONDARY outcome
Timeframe: Baseline (Highest non-missing pre-dose assessment from Day-9 and Day 1), Day 90Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
An incremental shuttle walk test is an externally paced maximal exercise test which determined a participant's peak exercise capacity. The maximum duration of the test is 20 minutes. Peak performance was measured in meters, which was defined as the maximum distance covered by a participant until the participant can no longer continue walking during this test. Baseline was defined as the highest non-missing pre-dose assessment from Day -9 and Day 1. Analysis was performed using ANCOVA model. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Outcome measures
| Measure |
Placebo- Male Participants
n=18 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=20 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=19 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=18 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Peak Performance From Incremental Shuttle Walking Test
|
-7.5 Meters
Standard Error 15.84
|
-42.3 Meters
Standard Error 15.02
|
-10.5 Meters
Standard Error 14.76
|
-17.2 Meters
Standard Error 15.16
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 56Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
The CAT is a short and simple participant-completed questionnaire which was developed for use in routine clinical practice to measure the health status of participants with COPD. The CAT is an 8-item questionnaire suitable for completion by all participants diagnosed with COPD. Participants rated their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment). A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0-40. Higher scores indicated more severe disease impact. Day 1 (Pre-dose) was considered as a Baseline. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=21 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=21 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=19 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Score at Day 56
|
-0.4 Scores on a Scale
Standard Error 1.14
|
-1.0 Scores on a Scale
Standard Error 1.14
|
-0.8 Scores on a Scale
Standard Error 0.92
|
-1.2 Scores on a Scale
Standard Error 0.97
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 90Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
The CAT is a short and simple participant-completed questionnaire which was developed for use in routine clinical practice to measure the health status of participants with COPD. The CAT is an 8-item questionnaire suitable for completion by all participants diagnosed with COPD. Participants rated their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment). A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0-40. Higher scores indicated more severe disease impact. Day 1 (Pre-dose) was considered as a Baseline. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=18 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=20 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=18 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Score at Day 90
|
-1.4 Scores on a Scale
Standard Error 0.94
|
0.8 Scores on a Scale
Standard Error 0.90
|
-1.3 Scores on a Scale
Standard Error 0.79
|
-2.2 Scores on a Scale
Standard Error 0.85
|
SECONDARY outcome
Timeframe: Baseline (Day -9), Day 56Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
The daily PROactive instrument consisted of a PRO questionnaire and an activity monitor to measure participant experience of physical activity. It consisted of 9-item daily assessments covering 2 different domains (amount and difficulty). The 'amount' domain was covered by 2 questions combined with 2 activity monitor outputs. The 'difficulty' domain was covered by 5 questions. Individual domains were scored by simple adding items, gave raw score values 0 to 17 for 'amount' and 0 to 20 for 'difficulty'. The raw scores were then transformed to a 0 to 100 Rasch analysis based scale for each domain. Higher scores indicated worse experience with physical activity. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented for averaged weekly difficulty score.
Outcome measures
| Measure |
Placebo- Male Participants
n=12 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=13 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=17 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=12 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Participant Reported Outcome (PRO)Active Individual Component: Difficulty Score at Day 56
|
1.3 Scores on a Scale
Standard Error 2.16
|
-0.8 Scores on a Scale
Standard Error 2.08
|
3.7 Scores on a Scale
Standard Error 1.59
|
-1.1 Scores on a Scale
Standard Error 1.80
|
SECONDARY outcome
Timeframe: Baseline (Day -9), Day 90Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
The daily PROactive instrument consisted of a PRO questionnaire and an activity monitor to measure participant experience of physical activity. It consisted of 9-item daily assessments covering 2 different domains (amount and difficulty). The 'amount' domain was covered by 2 questions combined with 2 activity monitor outputs. The 'difficulty' domain was covered by 5 questions. Individual domains were scored by simple adding items, gave raw score values 0 to 17 for 'amount' and 0 to 20 for 'difficulty'. The raw scores were then transformed to a 0 to 100 Rasch analysis based scale for each domain. Higher scores indicated worse experience with physical activity. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented for averaged weekly difficulty score.
Outcome measures
| Measure |
Placebo- Male Participants
n=13 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=11 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=15 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=17 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Participant Reported Outcome (PRO)Active Individual Component: Difficulty Score at Day 90
|
2.8 Scores on a Scale
Standard Error 2.56
|
-1.2 Scores on a Scale
Standard Error 2.65
|
2.0 Scores on a Scale
Standard Error 1.90
|
-2.9 Scores on a Scale
Standard Error 1.84
|
SECONDARY outcome
Timeframe: Baseline (Day -9), Day 56Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
The daily PROactive instrument consisted of a PRO questionnaire and an activity monitor to measure participant experience of physical activity. It consisted of 9-item daily assessments covering 2 different domains (amount and difficulty). The 'amount' domain was covered by 2 questions combined with 2 activity monitor outputs. The 'difficulty' domain was covered by 5 questions. Individual domains were scored by simple adding items, gave raw score values 0 to 17 for 'amount' and 0 to 20 for 'difficulty'. The raw scores were then transformed to a 0 to 100 Rasch analysis based scale for each domain. Higher scores indicated worse experience with physical activity. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented for averaged weekly amount score.
Outcome measures
| Measure |
Placebo- Male Participants
n=12 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=13 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=17 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=12 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Participant Reported Outcome (PRO)Active Individual Component: Amount Score at Day 56
|
2.5 Scores on a Scale
Standard Error 1.83
|
2.3 Scores on a Scale
Standard Error 1.77
|
3.3 Scores on a Scale
Standard Error 1.09
|
0.2 Scores on a Scale
Standard Error 1.24
|
SECONDARY outcome
Timeframe: Baseline (Day -9), Day 90Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
The daily PROactive instrument consisted of a PRO questionnaire and an activity monitor to measure participant experience of physical activity. It consisted of 9-item daily assessments covering 2 different domains (amount and difficulty). The 'amount' domain was covered by 2 questions combined with 2 activity monitor outputs. The 'difficulty' domain was covered by 5 questions. Individual domains were scored by simple adding items, gave raw score values 0 to 17 for 'amount' and 0 to 20 for 'difficulty'. The raw scores were then transformed to a 0 to 100 Rasch analysis based scale for each domain. Higher scores indicated worse experience with physical activity. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented for averaged weekly amount score.
Outcome measures
| Measure |
Placebo- Male Participants
n=13 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=11 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=15 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=17 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Participant Reported Outcome (PRO)Active Individual Component: Amount Score at Day 90
|
-0.8 Scores on a Scale
Standard Error 2.33
|
2.7 Scores on a Scale
Standard Error 2.47
|
-0.2 Scores on a Scale
Standard Error 2.05
|
3.8 Scores on a Scale
Standard Error 1.98
|
SECONDARY outcome
Timeframe: Baseline (Day -9), Day 56Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
The daily PROactive instrument consisted of a PRO questionnaire and an activity monitor to measure participant experience of physical activity. It consisted of 9-item daily assessments covering 2 different domains(amount and difficulty). The'amount'domain was covered by 2 questions combined with 2 activity monitor outputs. The 'difficulty'domain was covered by 5 questions. Individual domains were scored by simple adding items, gave raw score values 0 to 17 for'amount'and 0 to 20 for'difficulty. The raw scores were then transformed to a 0 to 100 Rasch scale for each domain. The 'total score' was obtained by calculating the average between two domains. Total score has the range from 0 to 100. Higher scores indicated worse experience with physical activity. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented
Outcome measures
| Measure |
Placebo- Male Participants
n=12 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=13 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=17 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=12 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Participant Reported Outcome (PRO)Active Total Score at Day 56
|
2.1 Scores on a Scale
Standard Error 1.09
|
0.5 Scores on a Scale
Standard Error 1.05
|
3.7 Scores on a Scale
Standard Error 0.89
|
-0.5 Scores on a Scale
Standard Error 1.03
|
SECONDARY outcome
Timeframe: Baseline (Day -9), Day 90Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
The daily PROactive instrument consisted of a PRO questionnaire and an activity monitor to measure participant experience of physical activity. It consisted of 9-item daily assessments covering 2 different domains(amount and difficulty). The'amount'domain was covered by 2 questions combined with 2 activity monitor outputs. The 'difficulty'domain was covered by 5 questions. Individual domains were scored by simple adding items, gave raw score values 0 to 17 for'amount'and 0 to 20 for'difficulty. The raw scores were then transformed to a 0 to 100 Rasch scale for each domain. The 'total score' was obtained by calculating the average between two domains. Total score has the range from 0 to 100. Higher scores indicated worse experience with physical activity. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Outcome measures
| Measure |
Placebo- Male Participants
n=13 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=11 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=15 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=17 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Participant Reported Outcome (PRO)Active Total Score at Day 90
|
1.2 Scores on a Scale
Standard Error 1.57
|
0.5 Scores on a Scale
Standard Error 1.66
|
1.3 Scores on a Scale
Standard Error 1.20
|
0.3 Scores on a Scale
Standard Error 1.14
|
SECONDARY outcome
Timeframe: Baseline (Day -9), Days 56 and 90Population: Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Steps per day was assessed using an accelerometer, a clinically validated physical activity monitor which was used to measure the levels of physical activity. Participants wore an accelerometer for 7 days during individual timepoint. Values at Baseline, Day 56 and Day 90 were the average values collected from an accelerometer for 7 days after the Day -9, Day 56 and Day 90. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Outcome measures
| Measure |
Placebo- Male Participants
n=14 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=17 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=17 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=17 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Steps Per Day (Physical Activity Measure) as Assessed Via an Accelerometer
Day 56,n=17,14,14,17
|
120.41 Steps per day
Standard Deviation 1282.092
|
-17.40 Steps per day
Standard Deviation 1334.539
|
285.19 Steps per day
Standard Deviation 1289.604
|
389.58 Steps per day
Standard Deviation 1322.701
|
|
Change From Baseline in Steps Per Day (Physical Activity Measure) as Assessed Via an Accelerometer
Day 90,n=17,17,14,14
|
-527.07 Steps per day
Standard Deviation 1077.747
|
611.36 Steps per day
Standard Deviation 1499.559
|
-246.45 Steps per day
Standard Deviation 756.414
|
786.21 Steps per day
Standard Deviation 1439.988
|
SECONDARY outcome
Timeframe: Baseline (Day -9), Days 56 and 90Population: Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Vector magnitude unit per wear time was assessed using an accelerometer, a clinically validated physical activity monitor which was used to measure the levels of physical activity. Participants wore an accelerometer for 7 days during individual timepoint. Values at Baseline, Day 56 and Day 90 were the average values collected from accelerometer for 7 days after the Day -9, Day 56 and Day 90. Data from an accelerator was uploaded to a central site. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Outcome measures
| Measure |
Placebo- Male Participants
n=14 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=17 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=17 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=17 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Vector Magnitude Unit Per Wear Time (Physical Activity Measure) as Assessed Via an Accelerometer
Day 56,n=17,14,14,17
|
56.42 Vector magnitude units per minute
Standard Deviation 86.284
|
71.98 Vector magnitude units per minute
Standard Deviation 175.403
|
9.19 Vector magnitude units per minute
Standard Deviation 82.596
|
-4.83 Vector magnitude units per minute
Standard Deviation 66.400
|
|
Change From Baseline in Vector Magnitude Unit Per Wear Time (Physical Activity Measure) as Assessed Via an Accelerometer
Day 90,n=17,17,14,14
|
-3.73 Vector magnitude units per minute
Standard Deviation 74.849
|
42.36 Vector magnitude units per minute
Standard Deviation 184.191
|
-6.60 Vector magnitude units per minute
Standard Deviation 65.648
|
0.40 Vector magnitude units per minute
Standard Deviation 64.670
|
SECONDARY outcome
Timeframe: Days 14, 28, 56 and 90Population: Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Participant-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to assess the participant's impression of change in their disease severity since the beginning of the study. Responses to the PGIC question were on a 7 point Likert scale: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. Number of participants with PGIC score is presented by treatment group, visit and by 7 response categories.
Outcome measures
| Measure |
Placebo- Male Participants
n=23 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=23 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=20 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 14, much better,n=21,20,23,23
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 14, much worse,n=21,20,23,23
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 14, worse,n=21,20,23,23
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 14, slightly worse,n=21,20,23,23
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 14, no change,n=21,20,23,23
|
9 Participants
|
9 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 14, slightly better,n=21,20,23,23
|
4 Participants
|
4 Participants
|
7 Participants
|
7 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 14, better,n=21,20,23,23
|
8 Participants
|
7 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 28, much worse,n=21,20,21,22
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 28, worse,n=21,20,21,22
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 28, slightly worse,n=21,20,21,22
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 28, no change,n=21,20,21,22
|
4 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 28, slightly better,n=21,20,21,22
|
10 Participants
|
7 Participants
|
9 Participants
|
6 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 28, better,n=21,20,21,22
|
5 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 28, much better,n=21,20,21,22
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 56, much worse,n=21,19,21,21
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 56, worse,n=21,19,21,21
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 56, slightly worse,n=21,19,21,21
|
1 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 56, no change,n=21,19,21,21
|
4 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 56, slightly better,n=21,19,21,21
|
7 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 56, better,n=21,19,21,21
|
8 Participants
|
5 Participants
|
10 Participants
|
6 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 56, much better,n=21,19,21,21
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 90, much worse,n=21,18,18,20
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 90, worse,n=21,18,18,20
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 90, slightly worse,n=21,18,18,20
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 90, no change,n=21,18,18,20
|
5 Participants
|
6 Participants
|
9 Participants
|
8 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 90, slightly better,n=21,18,18,20
|
9 Participants
|
9 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 90, better,n=21,18,18,20
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Day 90, much better,n=21,18,18,20
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Days 1 and 90Population: Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
PGRS is a single global question and was asked to participants to rate their COPD severity on a four point scale ranging from 1 to 4 (1=mild, 2=moderate, 3=severe, 4=very severe). Number of participants with PGRS score ranging from mild to very severe are presented over time.
Outcome measures
| Measure |
Placebo- Male Participants
n=23 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=23 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=20 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Participant Global Rating of Severity (PGRS) Score Over Time
Day 90, severe,n=21,18,18,20
|
8 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Participant Global Rating of Severity (PGRS) Score Over Time
Day 90, very severe,n=21,18,18,20
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Participant Global Rating of Severity (PGRS) Score Over Time
Day 1, mild,n=21,20,23,23
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Participant Global Rating of Severity (PGRS) Score Over Time
Day 1, moderate,n=21,20,23,23
|
11 Participants
|
12 Participants
|
9 Participants
|
13 Participants
|
|
Number of Participants With Participant Global Rating of Severity (PGRS) Score Over Time
Day 1, severe,n=21,20,23,23
|
12 Participants
|
8 Participants
|
8 Participants
|
7 Participants
|
|
Number of Participants With Participant Global Rating of Severity (PGRS) Score Over Time
Day 1, very severe,n=21,20,23,23
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Participant Global Rating of Severity (PGRS) Score Over Time
Day 90, mild,n=21,18,18,20
|
1 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Participant Global Rating of Severity (PGRS) Score Over Time
Day 90, moderate,n=21,18,18,20
|
9 Participants
|
2 Participants
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 90Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
SGRQ-c is the COPD specific version of SGRQ. It consisted of 40 items in total, corresponding to 3 individual domains (components): symptoms, activity and impact, with different components carrying a different weighting. Component scores were calculated by summing the weights from all positive items in that component, dividing by the sum of maximum possible weights for all items in that component, and multiplying this number by 100. Total score was calculated by summing the weight to all the positive responses in each component. Total score has the range from 0 to 100. Higher scores indicated more severe disease impact. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using ANCOVA model. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Outcome measures
| Measure |
Placebo- Male Participants
n=18 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=20 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=17 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in St. George Respiratory Questionnaire (SGRQ) for COPD (SGRQ-c) Total Score
|
-1.7 Scores on a scale
Standard Error 1.87
|
0.4 Scores on a scale
Standard Error 1.77
|
-3.9 Scores on a scale
Standard Error 1.71
|
-0.9 Scores on a scale
Standard Error 1.90
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 90Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
SGRQ-c is the COPD specific version of SGRQ. It consisted of 40 items in total, corresponding to 3 individual domains (components): symptoms, activity and impact, with different components carrying a different weighting. Component scores were calculated by summing the weights from all positive items in that component, dividing by the sum of maximum possible weights for all items in that component, and multiplying this number by 100. Symptoms component consisted of questions 1 to 7 in Part 1. Symptoms score has the range from 0 to 100. Higher scores indicated more severe disease impact. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using ANCOVA model. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Outcome measures
| Measure |
Placebo- Male Participants
n=18 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=20 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=17 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in SGRQ-c Symptoms Score
|
-3.5 Scores on a scale
Standard Error 3.38
|
-4.0 Scores on a scale
Standard Error 3.20
|
-4.0 Scores on a scale
Standard Error 2.95
|
-1.4 Scores on a scale
Standard Error 3.29
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 90Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
SGRQ-c is the COPD specific version of SGRQ. It consisted of 40 items in total, corresponding to 3 individual domains (components): symptoms, activity and impact, with different components carrying a different weighting. Component scores were calculated by summing the weights from all positive items in that component, dividing by the sum of maximum possible weights for all items in that component, and multiplying this number by 100. Activity component consisted of questions 9 and 12 in Part 2 of the questionnaire. Activity score has the range from 0 to 100. Higher scores indicated more severe disease impact. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using ANCOVA model. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Outcome measures
| Measure |
Placebo- Male Participants
n=18 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=20 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=17 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in SGRQ-c Activity Score
|
1.2 Scores on a scale
Standard Error 2.57
|
1.6 Scores on a scale
Standard Error 2.44
|
-5.4 Scores on a scale
Standard Error 2.00
|
-3.4 Scores on a scale
Standard Error 2.23
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 90Population: Analysis Population. Only those participants with data available at the specified data points were analyzed.
SGRQ-c is the COPD specific version of SGRQ. It consisted of 40 items in total, corresponding to 3 individual domains (components): symptoms, activity and impact, with different components carrying a different weighting. Component scores were calculated by summing the weights from all positive items in that component, dividing by the sum of maximum possible weights for all items in that component, and multiplying this number by 100. Impact component consisted of questions 8, 10, 11, 13, 14 in Part 2 of the questionnaire. Impact score has the range from 0 to 100. Higher scores indicated more severe disease impact. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using ANCOVA model. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Outcome measures
| Measure |
Placebo- Male Participants
n=18 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=20 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=17 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in SGRQ-c Impact Score
|
-2.7 Scores on a scale
Standard Error 1.76
|
0.8 Scores on a scale
Standard Error 1.67
|
-2.8 Scores on a scale
Standard Error 2.03
|
0.6 Scores on a scale
Standard Error 2.25
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 56 and 90Population: Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 measurements were collected using a spirometer. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Outcome measures
| Measure |
Placebo- Male Participants
n=21 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=21 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=19 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Day 56,n=21,19,21,21
|
0.012 Liters
Standard Deviation 0.1342
|
-0.016 Liters
Standard Deviation 0.2377
|
-0.000 Liters
Standard Deviation 0.0918
|
-0.028 Liters
Standard Deviation 0.0747
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Day 90,n=20,18,18,20
|
0.050 Liters
Standard Deviation 0.1130
|
0.007 Liters
Standard Deviation 0.2208
|
0.002 Liters
Standard Deviation 0.0970
|
-0.024 Liters
Standard Deviation 0.0833
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Days 56 and 90Population: Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
A bung size-specific to the participant was placed in the nostril deemed to be most patent by the investigator. The participant was asked to make a maximum voluntary sniff effort via a peak flow meter and the greatest effort from 10 repeat measurements were recorded. SnIP was measured in centimeter of water (cm H2O). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Outcome measures
| Measure |
Placebo- Male Participants
n=21 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=21 Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=19 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Sniff Nasal Inspiratory Pressure (SnIP)
Day 56,n=21,19,21,21
|
0.7 centimeter of water
Standard Deviation 17.82
|
-0.8 centimeter of water
Standard Deviation 15.51
|
-6.0 centimeter of water
Standard Deviation 11.20
|
3.4 centimeter of water
Standard Deviation 14.14
|
|
Change From Baseline in Sniff Nasal Inspiratory Pressure (SnIP)
Day 90,n=20,18,18,20
|
-1.2 centimeter of water
Standard Deviation 15.21
|
2.5 centimeter of water
Standard Deviation 21.39
|
-0.7 centimeter of water
Standard Deviation 8.55
|
-0.4 centimeter of water
Standard Deviation 11.34
|
SECONDARY outcome
Timeframe: Day 14 (Pre-dose), Day 28 (Pre-dose and at 1 to 4 hours Post-dose), Day 56 (at 5 to 8 hours Post-dose), Day 90 (Pre-dose)Population: Pharmacokinetic Population comprised of participants in the 'All Participants (all randomized participants who received at least one dose of study medication)'' Population for whom a PK sample was obtained and analyzed for GSK2881078.
Blood samples were collected at designated timepoints. Pharmacokinetics (PK) parameters of GSK2881078 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Placebo- Male Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=24 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Clearance (CL) of GSK2881078 Following Oral Dose in Participants
|
—
|
—
|
0.393 Liters per hour
Geometric Coefficient of Variation 59.5
|
0.476 Liters per hour
Geometric Coefficient of Variation 44.0
|
SECONDARY outcome
Timeframe: Day 14 (Pre-dose), Day 28 (Pre-dose and at 1 to 4 hours Post-dose), Day 56 (at 5 to 8 hours Post-dose), Day 90 (Pre-dose)Population: Pharmacokinetic Population
Blood samples were collected at designated timepoints. PK parameters of GSK2881078 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Placebo- Male Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
Placebo- Female Participants
n=21 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=24 Participants
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
|---|---|---|---|---|
|
Volume of Distribution at Steady State (Vss) of GSK2881078 Following Oral Dose in Participants
|
—
|
—
|
39.4 Liters
Geometric Coefficient of Variation 16.3
|
48.3 Liters
Geometric Coefficient of Variation 29.8
|
Adverse Events
Placebo- Female Participants
GSK2881078 1.0 mg- Female Participants
Placebo- Male Participants
GSK2881078 2.0 mg- Male Participants
Serious adverse events
| Measure |
Placebo- Female Participants
n=23 participants at risk
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=24 participants at risk
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
Placebo- Male Participants
n=24 participants at risk
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=25 participants at risk
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Diverticulitis
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
4.3%
1/23 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
Other adverse events
| Measure |
Placebo- Female Participants
n=23 participants at risk
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 1.0 mg- Female Participants
n=24 participants at risk
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
|
Placebo- Male Participants
n=24 participants at risk
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
|
GSK2881078 2.0 mg- Male Participants
n=25 participants at risk
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
26.1%
6/23 • Number of events 6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
29.2%
7/24 • Number of events 8 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
8.3%
2/24 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
12.0%
3/25 • Number of events 4 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
8.3%
2/24 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.0%
1/25 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.3%
1/23 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.0%
1/25 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
12.5%
3/24 • Number of events 5 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
8.3%
2/24 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
8.0%
2/25 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.3%
1/23 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
8.3%
2/24 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
12.0%
3/25 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
12.5%
3/24 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
8.0%
2/25 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
8.0%
2/25 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
4.3%
1/23 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.0%
1/25 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.3%
1/23 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Infections and infestations
Nasopharyngitis
|
21.7%
5/23 • Number of events 5 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
8.3%
2/24 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.0%
1/25 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Infections and infestations
Urinary tract infection
|
4.3%
1/23 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.0%
1/25 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.0%
1/25 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
1/23 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.0%
1/25 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.0%
1/25 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
General disorders
Chest pain
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.0%
1/25 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
General disorders
Fatigue
|
4.3%
1/23 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.0%
1/25 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
General disorders
Non-cardiac chest pain
|
4.3%
1/23 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Injury, poisoning and procedural complications
Contusion
|
13.0%
3/23 • Number of events 3 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
8.0%
2/25 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.0%
1/25 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Investigations
Blood 25-hydroxycholecalciferol decreased
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
8.3%
2/24 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.0%
1/25 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Vascular disorders
Hypertension
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
8.3%
2/24 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Vascular disorders
Haematoma
|
4.3%
1/23 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Vascular disorders
Hypotension
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
8.3%
2/24 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Nervous system disorders
Headache
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
8.3%
2/24 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
8.0%
2/25 • Number of events 2 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.3%
1/23 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.0%
1/25 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.0%
1/25 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.0%
1/25 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.0%
1/25 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/23 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
0.00%
0/24 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
|
4.0%
1/25 • Number of events 1 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132
SAEs and non-serious AEs were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER